1. Field of the Invention
This invention relates generally to topical pharmaceutical formulations, and more particularly to a topical formulation combination of ingredients for use in combating fungal infections, the formulation including tolnaftate as an active agent and benzalkonium chloride as a preservative.
2. Description of Related Art
The following art defines the present state of this field:
Levin, U.S. Pat. No. 5,656,301 describes a topical composition comprising LYCD together with known topically active useful medicinal agents such as anti-wrinkling, antibiotic, anticancer, antifungal, anti-inflammatory such as anti-acne, antiviral, wound healing, and hair-growing agents. The LYCD works together with the other active agents to achieve a synergistic result more effective than can be obtained from the topical agents individually, and more effective than could be predicted from the mere addition of the known efficacies of the individual ingredients.
Levin, U.S. Pat. No. 5,656,300 describes a topical composition comprising LYCD together with known topically active useful medicinal agents such as anti-wrinkling, antibiotic, anticancer, antifungal, anti-inflammatory such as anti-acne, antiviral, wound healing, and hair-growing agents. The LYCD works together with the other active agents to achieve a synergistic result more effective than can be obtained from the topical agents individually, and more effective than could be predicted from the mere addition of the known efficacies of the individual ingredients.
Levin, U.S. Pat. No. 5,023,090 describes a topical composition comprising LYCD together with known topically active useful medicinal agents such as anti-wrinkling, antibiotic, anticancer, antifungal, anti-inflammatory such as anti-acne, antiviral, wound healing, and hair-growing agents. The LYCD works together with the other active agents to achieve a synergistic result more effective than can be obtained from the topical agents individually, and more effective than could be predicted from the mere addition of the known efficacies of the individual ingredients.
Levin, U.S. Pat. No. 5,714,169 describes a topical composition comprising LYCD together with known topically active useful medicinal agents such as anti-wrinkling, antibiotic, anticancer, antifungal, anti-inflammatory such as anti-acne, antiviral. Wound healing, and hair-growing agents. The LYCD works together with the other active agents to achieve a synergistic result more effective than can be obtained from the topical agents individually, and more effective than could be predicted from the mere addition of the known efficacies of the individual ingredients.
Levin, U.S. Pat. No. 5,667,810 describes a topical composition comprising LYCD together with known topically active useful medicinal agents such as anti-wrinkling, antibiotic, anticancer, antifungal, anti-inflammatory such as anti-acne, antiviral, wound healing, and hair-growing agents. The LYCD works together with the other active agents to achieve a synergistic result more effective than can be obtained from the topical agents individually, and more effective than could be predicted from the mere addition of the known efficacies of the individual ingredients.
Levin, U.S. Pat. No. 5,676,973 describes a topical composition comprising LYCD together with known topically active useful medicinal agents such as anti-wrinkling, antibiotic, anticancer, antifungal, anti-inflammatory such as anti-acne, antiviral would healing, and hair-growing agents. The LYCD works together with the other active agents to achieve a synergistic result more effective than can be obtained from the topical agents individually, and more effective than could be predicted from the mere addition of the known efficacies of the individual ingredients.
Benzalkonium chloride, a mixture of alkylbenzyldimethylammonium chlorides in which the alkyls are long chain compounds (C.sub.8 to C.sub.18), and related quaternary ammonium chlorides, have been used as surface-active germicides for many pathogenic non-sporulating bacteria and fungi and as antimicrobial agents in cosmetics and pharmaceutical products as described in U.S. Pat. No. 5,492,932. They have also been used in formulations in combination with protease inhibitors, as skin treatment agents, as taught in U.S. Pat. No. 5,346,886.
Formulations containing tolnaftate (o-2-Naphthyl m,N-dimethylthiocarbanilate) have been used extensively to treat various topical fungal infections. There are several related pharmaceutical preparations for topical use including lotions and sprays containing tolnaftate as an active agent. These products are available commercially as Aftate.RTM. aerosol liquid, Desenex.RTM. spray liquid, Tinactin.RTM. liquid and lotion and other products; see U.S. Pat. No. 5,519,059. Products containing tolnaftate in combination with cortisone have been developed for topical use against fungal infection as described in U.S. Pat. No. 5,496,812. Finally, preparations containing tolnaftate have also been developed to treat the infection of herpes simplex virus as shown in U.S. Pat. No. 4,438,134.
The prior art teaches topical formulations for the treatment of fungal and other infections. However, the prior art does not teach that the combination of tolnaftate and benzalkonium chloride may be used to significant advantage as a preferred agent for combating fungal infection. The present invention teaches this highly effective, yet unknown combination and provides further related advantages as described in the following summary.